Archive | Regulatory

Pembrolizumab Moves Toward EU Approval for Resected Stage IIB/IIC Melanoma

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of pembrolizumab (Keytruda) for use as adjuvant therapy in adult and adolescent patients aged 12 years and older with stage IIB or IIC melanoma following complete resection. Additionally, CHMP recommended expanding the indication for pembrolizumab in advanced unresectable or […]

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Posted in Melanoma News, Regulatory, Publications

EMA adopts positive opinion for Keytruda in melanoma following complete resection

A committee of the European Medicines Agency recommended the approval for expanded use of Keytruda (pembrolizumab) as a standalone therapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma who have undergone complete resection.

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Posted in Melanoma News, Regulatory, Publications

Positive FDA Feedback Supports BLA Submission for Lifileucel in Melanoma

The FDA has provided positive feedback regarding Iovance Biotherapeutics, Inc.’s proposed matrix of potency assays for an upcoming biologics license application (BLA) seeking the approval of lifileucel (LN-144) in the treatment of patients with metastatic melanoma.

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Posted in Melanoma News, Regulatory, Publications

FDA Grants Fast Track Designation to 7HP349 for Anti-PD-1 Metastatic Melanoma

Fast track designation has been granted to 7HP349, in combination with a CTLA-4 inhibitor for the treatment of patients with unresectable or metastatic malignant melanoma following treatment failure with a PD-1 inhibitor.

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Posted in Melanoma News, Regulatory, Publications